Documentation and SOP requirements. How to format a SOP. Importance of documentation

Documentation and SOP requirements

1. Standard Opertaing Procedures

2. 2 Definition An SOP is a set of written instructions that document a routine or repetitive activity. It is a set of detailed written instructions to achieve uniformity of the performance of a specific function. A standard operating procedure or SOP is a set of instructions that address the “who, what, where and when” of an activity. .

3. 3 What are SOPs? In simple terms a SOP is… A written process A way for the clinical site to perform a task the same way each time it is completed.

4. 4 Why Written Instructions are Required? Serve 6 important functions Performance standards Instruction Reference Review Control Documentation

5. 5 Why Written Instructions are Required? (contd) Performance standards- Important in establishing & enforcing work standards Help ensure same task is consistently performed by all workers Serve to define the acceptable level of performance for a task

6. 6 Why Written Instructions are Required? (contd) Instructions- Instruct the worker on “ how to ” Serve as training guideline Reference- Valuable reference containing detailed information of the steps Often difficult to remember every step in correct order Provide time-saving checklist to ensure that each step is correctly followed

7. 7 Why Written Instructions are Required? (contd) Review- Provides opportunity for critical review of each step thereby offers scope for improvement Control- Tells us what to look for when we audit our procedures Also serve as personal controls to avoid performing wrong steps Documentation- Serve as the basic record of how the task is performed which is critical for success

8. 8 SOPs are used to: Identify the responsible person for each task. Describe actions (what is to be completed). Train staff. Monitor site performance.

9. 9 When are SOPs needed? Repetitive actions or procedures Critically important procedures Ensuring quality control

10. 10 When SOPs help improve a system? When variation must be controlled When safety risks are present When numerous people perform the same procedure When objective feedback on performance is a goal When steps and decisions can be standardized

11. Why SOPs

12. 12 Writing SOPs Decide what SOPs are necessary Check existing SOPs Gather information Select a format Assemble necessary documents Determine process Common sense Logic Start at the beginning Step by step Stop at the end

13. 13 Writing SOPs: General Hints Avoid complex sentences and paragraphs Short, clear, concise words Be clear and precise. Use the same word for the same thing Define acronyms, etc Use active voice. Avoid names use appointments / designations

14. 14 Writing SOPs List steps and who (position) is responsible for carrying out each step. Don’t include steps that are done by people outside the organization (only include what that organization is responsible for).

15. 15 Level of Detail: Criteria for Including a Step or Sub step Is the step essential to completing the activity? Are there appropriate and inappropriate ways of completing the step? Will variation in how the step is completed affect the activity or regulatory compliance? Will variation in how the step is completed affect performance results? Will variation in how the step is completed significantly affect efficiency? Is there another significant reason why the step must be completed in a particular way?

16. 16 How much detail? Less detail = easier compliance More detail = easier for new employees to use Need to strike a balance!

17. 17 Example: Low Detail Make a grilled cheese sandwich. 1. Put cheese between bread slices. 2. Cook.

18. 18 Example: Medium Detail Make a grilled cheese sandwich. Put cheese between two slices of bread. Butter the outsides of the bread. Place in a frying pan over medium heat. When the bottom is golden brown, turn over and cook the other side until it is browned. Remove from pan, cut in half, and serve.

19. 19 Example: High Detail Make a grilled cheese sandwich. Slice medium cheddar cheese. Spread mustard on one slice of white bread. Put the sliced cheese on top of the mustard, and cover with a second slice of white bread. Using a table knife, generously butter the outside of the top piece of bread. Place the sandwich in a frying pan, buttered side down. Using the same knife, butter the outside of the top piece of bread. Place the frying pan with the sandwich in it on the stove burner, and turn the heat to medium high. Cook until the bottom is golden brown. Using a spatula, turn the sandwich over and cook the other side until it is browned. Using the spatula, remove the sandwich from pan and put it on a plate. Cut the sandwich in half on the diagonal in half. Garnish with three dill pickle slices and serve.

20. 20 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Critera References Records This must describe in sufficient detail the focus of the SOP so that anyone can tell from the title the content of the SOP when searching a list of SOPs This more important than you think!

21. 21 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Critera References Records What is to be accomplished This often will duplicate the title of the SOP: Title Writing, Review and Approval of Standard Operating Procedures Purpose To define the process used to write, review and approve standard operating procedures of the Quality Assurance Unit

22. 22 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Critera References Records The scope defines the area to which the SOP applies: This procedure applies to all policies and procedures used by the Quality Assurance Unit

23. 23 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Critera References Records This states who has responsibility for training and execution of the SOP: It is the responsibility of the Quality Assurance Manager or designee to assure that all Quality Assurance Specialists are trained on and comply with this standard operating procedure

24. 24 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Critera References Records Use words such as- Shall Must Will When more than one person carries out an activity do not use- Should May When only one person carries out an activity, begin each activity with an active verb such as- Analyze Begin Check Delete Enter Start Store Submit

25. 25 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Criteria References Records Indicators measuring Efficiency of the process Eg . Waiting time at registration counter Turn around time for Lab test

26. 26 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Criteria References Records Indicators measuring Efficiency of the process Eg . Waiting time at registration counter Turn around time for Lab test

27. 27 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Criteria References Records External Guidelines Reference to Other SOPs

28. 28 Suggested Format Title Purpose Scope Definitions Process Owners Procedure Process Efficiency Criteria References Records List all the records generated during these procedures

29. Life Cycle of SOPs SOP Implementation

30. Involve People SOP is a operational tool. The process owner knows better what and how can be implemented. So it is critical to involve the departmental in charges and process owners while writing the SOPs . A base draft can be circulated to process owners so they can review it at point of use and give their feed back on it. Single handily written sops with no inputs from the front line worker may lead to poor implementation.

31. Ensure Availability The basic principle is that each worker should know what he/ore she has to do. So SOPs and work instruction should be available with them It is also necessary that give only the relevant SOPs/Part of SOPs. A bulky document with lot of irrelevant processes that worker do not deal with, lead to poor acceptability of document If it is not possible to provide copy of SOPs to every staff than it should be kept at place from it is easily accessible.

32. Keep it Simple Information overload is also bad. People should know precisely what they have to do. Never club the processes, write one process in one column. Write process in present tense as in there ‘are’ performed and not in future tense as they ‘will’ be preformed

33. User Friendly Wherever possible use illustrations & flow chart for illustrations. Some SOPs may be used by the staff those are not knowing English, so after customization of these SOPs translate the relevant SOPs into local language.

34. Visual Management SOPs and work instructions lying cupboards are of no use. Display relevant procedures and work instructions at point of use. caution , do not over do. Only the relevant one. Work instructions should as possible pictorial.

35. Use SOPs enablers Use SOPs as tool for training. Only class room training will not do . Provide hands on training on SOPs reinforced by continuos monitoring.

36. Keep SOPs up to Date SOPs are dynamic documents. If a new process is added at you facility, add it to relevant SOP also. Accordingly their may be suggestions for improving a existing process , start it with amending the process in your SOP. Similarly any new advancement or technical requirements should be incorporated in the SOP.

37. Use SOPs as assessment tools During the periodic assessment process use SOPs as criteria for assessment. Try to see people are working according to the procedures in the SOPs or not.

38. Clear cut Responsibility Responsibility for doing a particular job should be clearly written against the process. For critical processes try to do define the alternate responsible person, if the appointed person is not available, in case.

39. Create a buy in Some time introducing SOPs create apprehension, that it will increase their work and will lead to stricter monitoring. It is necessary that staff should know its importance and benefits they will get by using the SOPs. So addressing ‘What’s in it for me’ is critical to success for implementation of SOPs.

40. Recognize and Reward Champions Creating an internal environment for quality is must for long term sustenance. Recognize and rewards the departments and staff those are adhering to SOPs. Motivate others to follow the campions.

41. NQAS Certification Dr. Parminder Gautam

42. Documents and evidences to be submitted Customised Standards A copy of customized standards with approval from CQAC Internal assessment by Facility/District team Complete Assessment Report and Scores  Details of Assessment Team (Name & Designation). Approved Internal Assessment Plan for One year.  Internal Assessment by State team Assessment Schedule. Details of Assessment Team (Name & Designation). Complete Assessment Report and Scores. All Filled checklists and Scores.

43. Quality Policy, Vision, Mission and Quality Objectives quality Policy. Quality Policy is approved by head of institution. Overall Quality Objectives of Hospital     Quality objectives of all Departments Quality objectives should be in line with Quality Policy Quality objectives are SMART ? Evidence of monitoring and Tracking Quality Objectives.      

44. Operational Quality Team Supporting Document/Office order regarding constitution of Quality Team. Quality Team is multi-disciplinary with representation from all departments (Clinical, Admin, Support) Records of proceedings (MOM) of at least three consecutive monthly meeting.      

45. Standard Operating Procedures (SOP) All required SOPs are submitted.   All SOPs should be drafted and approved by competent Authority. All SOPs adequately describes the process and have details as per NQAS.      

46. Sr no Name of Document 1 Accident & Emergency Department 2 Out Patient Department 3 Labor Room 4 Maternity Ward 5 Paediateric Ward 6 Nutritional Rehabilitation Centre 7 Sick New Born Care Unit 8 Operation Theater 9 Post Partum Unit 10 Intensive Care Unit 11 Inpatient Department 12 Laboratory Services 13 Radiology /USG 14 Pharmacy Services 15 Laundry Services 16 Dietary Services 17 Medical Record Department 18 Post Mortem 19 Blood Bank 20 TSSU/CSSD 21 Inventory & Store 22 Hospital Improvement manual 23 Facility management System/ General Checklist List of SOP’s required

47. Quality Improvement Manual Quality Manual shall be approved by competent Authority. Manual shall be complete in all respects Quality Manual shall adequately describes the process as per NQAS .    

48. Defined and documented Policies. Condemnation Policy. End of Life Care Policy       Antibiotic Policy       Visitor Policy       Non -Discrimination to Gender Policy     Religious and Cultural Preferences Policy.       Social Non-Discrimination Policy.       Privacy , Dignity and Confidentiality Policy       Maintenance of Patient Records and information Policy.       Privacy of patients with social stigma Policy.       Consent Policy       Change of linen in patient care area Policy.     Judicial use of PPEs Policy       Prescription by Generic names Policy       Reporting of Adverse Events Policy     Referral of patients if services cannot be provided Policy       Consultation of patients within Hospital Policy       Handover during interdepartmental transfer Policy       Internal adjustments in case of non-availability of beds Policy       Dress Code Policy       Narcotic Drugs and Psychotropic substances Policy       Policy for avoiding stock outs of drugs and consumables and ensuring availability of drugs as per EDL.       Policy for regular competence testing as per job description.       Policy for Timely reimbursements of entitlements and compensation.       Policy for ensuring free of cost treatment to BPL patients.       Grievance redressal Policy       No smoking Policy       Quality Policy.      

49. Patient Satisfaction Surveys & Key Performance Indicators (KPIs) Records of at least 3 consecutive Patient satisfaction surveys (Both OPD and IPD).     Analysis of the surveys.       Records of at least 3 months of KPIs.       Action Plan.       Action plan is based on internal Assessment's findings.     Actions taken.      

50. Audit Records

51. Criteria for National Certification-DH Criteria requirements Criterion 1 Aggregate score of the health facility ≥ 70% Criterion 2 Score of each department of the health facility ≥ 70% Criterion 3 Segregated score in each Area of Concern ≥ 70% Criterion 4 Score of Standard A2, Standard B5 and Standard D10 is > 70% in each applicable department. Criterion 5 Individual Standard wise score ≥ 50% Criterion 6 Patient Satisfaction Score of 70% in the preceding Quarter or more (Satisfied & Highly Satisfied on Mera-Aspataal) or Score of 3.5 on Likert Scale

52. Award of Certification Certification – H ealth facility meets all 6 criteria. Certification with Conditionality – Meets Critieria 1 -aggregate score is 70% or more + at least three criteria out of remaining five (Criterion II, III, IV, V & VI) facility is required to submit evidence of having addressed the reasons of conditionality, . Within agreed timeframe of six months, If the hospital does not meet the conditionality in stipulated time-frame, the QA certification may be revoked after giving one more chance for a period of six months. Deferred Certification – The certification may be deferred until follow-up assessment if Hospital overall score is 70% in external assessment, but does not meet the criteria for conditional certification. Certification declined - If hospital does not score 70% in external assessment the certification will be declined. The hospital may freshly apply for certification but not before one year of declaration of external assessment result .

53. Surveillance and Re-certification Certification / recertification would be valid for a period of three years , subject to validation of compliance to the QA Standards by the SQAC team every year for subsequent two years. In the third year , the facility would undergo re-certification assessment by the National Assessors after successful completion of two surveillance audits by the SQAC.

54. Criteria for National Certification-CHC/UCHC Criteria requirements Criterion 1 Aggregate score of the health facility ≥ 70% Criterion 2 Score of each department of the health facility ≥ 70% Criterion 3 Segregated score in each Area of Concern ≥ 70% Criterion 4 Score of Standard A2, Standard B5 and Standard D10 is > 6 0% in each applicable department. Criterion 5 Individual Standard wise score ≥ 50% Criterion 6 Patient Satisfaction Score of 65% in the preceding Quarter or more (Satisfied & Highly Satisfied on Mera-Aspataal) or Score of 3.5 on Likert Scale

55. Criteria for National Certification-PHC/UPHC Criteria requirements Criterion 1 Aggregate score of the health facility ≥ 70% Criterion 2 Segregated score in each Area of Concern ≥ 60% Criterion 3 Score of Standard A2, Standard B4 and Standard F6 is > 6 0% in each applicable department. Criterion 4 Individual Standard wise score ≥ 50% Criterion 5 Patient Satisfaction Score of 60% in the preceding Quarter or more (Satisfied & Highly Satisfied on Mera-Aspataal) or Score of 3.5 on Likert Scale

56. Thank You Bridging Quality and Patient Care

57. Task for today Review the SOPs Add / Amend / Delete processes according to the processes in your hospital Align SOPs with requirements of National Quality Assurance Standards. Any other suggestion